N/A
N=80
Hyperthermic Yoga for Depressive Symptoms
Depression · Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02607514 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Depressive Symptoms as Measured by the Inventory of Depressive Symptomatology - Clinician Rated (IDS-CR) — 17.93; 29.63 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- hyperthermic yoga (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Depressive Symptoms as Measured by the Inventory of Depressive Symptomatology - Clinician Rated (IDS-CR) |
17.93; 29.63 | — |
| PRIMARY Feasibility and Tolerability Measured by Percent of the Yoga Group Who Complete a Week 8 Assessment |
27; 32 | — |
| PRIMARY Acceptability as Measured by the Acceptability Interview Completed at 8-week Endpoint or Early Termination |
7.17; 7.52; 8.33; 8.59; 6.90; 7 | — |
| SECONDARY Quality of Life as Measured by the Quality of Life Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) Over 8 Weeks. |
51.33; 41.34 | — |
| SECONDARY General Health as Measured by the Medical Outcomes Study 36-item Short-form Survey (SF-36) |
61.67; 53.5 | — |
| SECONDARY Physical Functioning as Measured by the Physical Component Scale (PCS) of the Medical Outcomes Study 36-item Short-form Survey (SF-36) Over 8 Weeks. |
47.62; 53.33 | — |
| SECONDARY Perceived Stress as Measured by the Perceived Stress Scale (PSS) Over 8 Weeks. |
17.42; 22.33 | — |
| SECONDARY Anxiety as Measured by the Spielberger State-Trait Anxiety Inventory (STAI), State, Over 8 Weeks. |
40.69; 48.43 | — |
| SECONDARY Sleep as Measured by the Pittsburg Sleep Quality Index (PSQI): A Commonly Used and Well-validated Self-rated Measure of Sleep-quality and Disturbance Over 8-weeks. |
— | — |
| SECONDARY Long Term Effects of Heated Yoga Intervention as Measured by All Primary and Secondary Outcomes After 1 Month Post-intervention. |
— | — |
| SECONDARY Anxiety as Measured by the Spielberger State-Trait Anxiety Inventory (STAI), Trait, Over 8 Weeks. |
46.70; 54.1 | — |
Summary
Study is a randomized controlled trial to assess the feasibility, acceptability, efficacy, and mechanisms of action of hyperthermic yoga versus a waitlist control for 80 medically healthy adults with mild to moderate depressive symptoms. The primary aim is to test the acceptability and feasibility of hyperthermic yoga as a treatment for depression. The secondary aim is to examine the effect size/efficacy of hyperthermic yoga for depressive symptoms. The tertiary aim is to explore physiological and psychological mechanisms of action.
Eligibility Criteria
Inclusion Criteria
- Adults ages 18-60
- English language proficiency
- Ability to provide informed consent
- Score of >23 on the Inventory of Depressive Symptomatology - Clinician Rated (IDS-CR)
- Able and willing to attend two 90-minute hyperthermic yoga sessions per week
- Willingness to keep existing exercise regimen (even if that is sedentary) stable over study course
- Women of childbearing potential must use an acceptable form of birth control
- Membership to the Bikram Yoga Boston and Bikram Yoga Cambridge studios via studio website "Interested in research" option through a centralized portal (this will remain central until January 1, 2017)
- Willingness to adhere to hydration requirements (i.e., an additional four 8 oz servings of water pre- and post-yoga classes)
Exclusion Criteria
- Pregnancy or planned pregnancy during study
- History of psychiatric hospitalization within the past year
- Active suicidal intent within the past year ("yes" on item 4 or 5 on the Columbia-Suicide Severity Rating Scale)
- History of neurologic disorders that could interfere in study participation
- History of bipolar disorder, psychotic disorders, eating disorders, and/or substance abuse or dependence (within the last year), as per the Mini-International Neuropsychiatric Interview (MINI)
- Psychotropic medication use that has been stable for 140 systolic and/or >90 diastolic], hypotension [ 6 one hour classes of meditation or other mind-body disciplines (e.g., Tai chi or yoga) within the last 6 months
- Current individual or group psychotherapy established for <3 months
- A subject who in the opinion of the Principal Investigator would not be able to safely complete the study or would jeopardize study integrity
- History of heat intolerance or heat stroke
- Unsafe cardiac status as defined by abnormal ECG reading at screening visit as determined by medical monitor, study doctor, or subject's PCP or cardiologist
Data sourced from ClinicalTrials.gov (NCT02607514). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.